IOL for reducing secondary opacification

ABSTRACT

An IOL implantable in an eye including an optic having an optical portion for directing light toward the retina of the eye and a cell barrier portion for inhibiting cell growth from the eye in front of or in back of the optical portion. The cell barrier portion circumscribes the optical portion, is incapable of focusing light on the retina and includes an irregularly configured structure, for example, irregular grooves. At least one elongated fixation member is coupled to the optic for use in fixing the optic in the eye.

This is a division of application Ser. No. 08/437,656, filed May 9,1995, now U.S. Pat. No. 5,549,670.

BACKGROUND OF THE INVENTION

This invention relates to intraocular lenses and in particular tointraocular lenses (IOL's) which reduce secondary opacification.

An intraocular lens is commonly used to replace the natural lens of thehuman eye when warranted by medical conditions. It is common practice toimplant an IOL in a region of the eye known as the capsular bag orposterior capsule.

One problem that is experienced with many IOL's following theirimplantation is that cells from the eye, particularly lens epithelialcells from the capsular bag, tend to grow on the capsular bag in frontof and/or in back of the optical portion of the IOL. This tends to blockthe optical portion of the IOL and to impair vision.

A common treatment for this condition is to use a laser to destroy thecells and a central region of the capsular bag. Although this treatmentis effective, the laser is expensive and is not available throughout theworld. There is also cost associated with the laser treatment as well assome patient inconvenience and risk of complications. Finally, the lasertreatment may affect the performance of some IOL's.

Davenport U.S. Pat. No. 4,743,254 discloses an IOL which includes glarereducing sections on the opposite sides of an optic. These glarereducing sections are fully or partially opaque and their surfaces arenot smooth. It has been observed that cell migration across the glarereducing sections appears to be reduced. A similar result has beenobserved in a plate IOL in which a plate, which is used as a haptic forfixing the IOL in the eye, surrounds the optic. Specifically cellmigration across the plate, which has a somewhat textured surface,appears to be reduced.

Kelman U.S. Pat. No. 4,808,181 discloses an IOL including a lensassembly having an anterior surface formation and a posterior surfaceformation. At least a portion of the posterior surface formationconstitutes a planar contact region adapted to seat against theposterior capsule of the eye to permanently anchor the lens assembly.The contact region is provided with a roughened surface area defined bya series of ordered narrow linear depressions extending transverse ofthe plane of the contact region. This patent teaches that these orderednarrow linear depressions accelerate adhesion and enhance anchoring ofthe tissue of the posterior capsule to the lens assembly. This patent isnot concerned with secondary opacification and provides no solution tothis problem.

SUMMARY OF THE INVENTION

This invention provides an IOL which is believed to solve the secondaryopacification problem discussed above. With this invention, an opticalportion, which is adapted to be placed in the capsular bag of an eye,directs light toward the retina of the eye, and a cell barrier portioncircumscribes the optical portion. With this construction, the opticalportion serves the normal function of directing and focusing light at ornear the retina. The cell barrier portion inhibits cell growth from theeye, for example, from the capsular bag, in front of and/or in back of(behind) the optical portion. The optical portion and the cell barrierportion may be considered as being portions of the optic.

The cell barrier portion of the optic circumscribes the optical portionso as to not leave any path available for the migration of cells infront of or in back of the optical portion. The cell barrier portion isconstructed so as to be incapable of or ineffective in focusing light onthe retina. The cell barrier portion is preferably partially or whollyopaque to eliminate light scattering.

At least one fixation member, preferably an elongated fixation member,is coupled to, and preferably extends outwardly from, the optic for usein fixing the optic in the eye. Viewed from a different perspective, astructure other than the cell barrier portion is employed for fixing theoptic in the eye. Such structure may include one or more fixationmembers of various different configurations coupled to the optic. Thefixation members may be separate members attached to the optic ormembers which are integral with the optic, and they may compriseelongated filaments or one or more wider plate or plate-like members.

The cell barrier portion may be of any construction which performs thefunction of inhibiting cell growth from the eye in front of or in backof the optical portion. In this regard, the cell barrier portion mayinclude an irregularly configured structure or surface feature, such isan irregularly roughened or textured surface region and/or one or moreannular grooves which are at least partially defined by irregularsurfaces.

As used herein, the terms "irregular" or "irregularly" refer to a thing,for example, an irregularly roughened surface region, or series ofthings, for example, irregular surfaces, which do not have a consistentorder, pattern or configuration. In one embodiment, these terms refer toa thing or series of things which are substantially unordered or whichhave a pattern or configuration with a significant or substantial degreeof randomness, or even substantially complete randomness. Withparticular regard to the annular groove or grooves described herein, theirregular surfaces which at least partially define, preferably whichdefine a major portion of and more preferably which substantiallycompletely define, such groove or grooves are represented by other thanstraight lines, for example, other than straight lines having a lengthmore than about 0.001 mm or about 0.0005 mm, with the groove or groovesviewed in axial cross-section, that is in cross-section along a planewhich includes the central optical axis of the optical portion. Theannular grooves are not to be considered regular simply because they arepresent in a concentric array with each groove being substantiallyequally spaced apart from the adjacent groove or grooves. In oneembodiment, the irregularity in accordance with the present invention issufficient to result in the irregularly configured structure, present inan otherwise optically clear cell barrier portion to be at least about50% opaque (that is frosty or hazy), more preferably at least about 80%opaque and still more preferably substantially completely opaque.

The irregularly configured structure or surface feature of the cellbarrier portion preferably has a radial dimension of no more than about2 mm, more preferably no more than about 0.75 mm and still morepreferably no more than about 0.25 mm. If the cell barrier portionincludes an annular groove, the groove preferably has a maximum widthand a maximum depth each no greater than about 0.02 mm. In one preferredconstruction, the cell barrier portion includes at least about 20annular grooves.

The optic has anterior and posterior faces. The irregularly configuredstructure, for example, surface roughening or texturing and/or grooves,may be provided on any surface or surfaces along which the cells maymigrate and completely circumscribes the optical portion. Preferably,the irregularly configured structure is provided at least on theposterior face and/or anterior face of the optic in the cell barrierportion.

The irregularly configured structure or surface feature can be includedin/on the cell barrier portion using any suitable technique ormethodology. Of course, it is important that this structure or surfacefeature be sufficiently irregular to achieve the desired inhibition ofcell migration or cell growth so that the risk of secondaryopacification is reduced. The technique or methodology chosen to includethis structure or surface feature should take this basic criterion intoaccount. This structure or surface feature can be formed during theinitial formation, for example, the molding, of the cell barrier portionor optic, or can be included after the cell barrier portion or optic isproduced, for example, using a laser, lathe, other mechanical implementand the like. In one particularly useful embodiment, a lathe is employedto form a spiral array of annular grooves defined by irregular surfacesin the cell barrier portion. Cell barrier portions may be processed in amanner similar to the glare reducing sections of Davenport U.S. Pat. No.4,743,254 to yield fully or partially opaque structures the surfaces ofwhich are irregular and not smooth. The disclosure of this patent isincorporated in its entirety herein by reference.

The cell barrier portion may be integral with the optical portion, ormay be a separate member coupled to the optical portion. Also, thefixation member or members may be integral with the cell barrier portionand/or the optical portion, or may be a separate element or elements,e.g., filament or filaments, coupled to the optical portion or the cellbarrier portion.

The invention, together with additional features and advantages thereofmay best be understood by reference to the following description takenin connection with the accompanying illustrative drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of one form of IOL constructed in accordance withthe teachings of this invention.

FIG. 1A is an elevational view of the IOL shown in FIG. 1.

FIG. 2 is an enlarged fragmentary view of the region generally boundedby the arc 2 in FIG. 1 and showing a more detailed view of the cellbarrier portion of the IOL.

FIG. 3 is an enlarged fragmentary sectional view taken generally along3--3 of FIG. 2.

FIG. 4 is an enlarged fragmentary sectional view taken generally alongline 3--3 of FIG. 2 and showing the growth of cells from the capsularbag of the eye on only a portion of the cell barrier region.

FIG. 5 is an enlarged fragmentary view of the region generallyidentified by the line 5--5 in FIG. 3 and showing the substantialirregularity of the grooves of the cell barrier portion.

FIG. 6 is a photograph of a portion of a cell barrier portion of an IOLin accordance with the present invention at 1000 times magnification andshowing the irregular annular grooves.

FIG. 7 is a plan view of a second form of IOL constructed in accordancewith the teachings of this invention.

FIG. 8 is an enlarged fragmentary sectional view taken generally alongline 8--8 of FIG. 7.

FIG. 9 is a plan view with portions broken away of a third from of IOLconstructed in accordance with the teachings of this invention.

FIG. 10 is an enlarged fragmentary sectional view taken generally alongline 10--10 and illustrating another construction of the cell barrierportion.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1 and 1A show an IOL 11 which generally comprises an optic 13 andfixation members 15 and 17. In this embodiment, the optic 13 may beconsidered as including an optical portion 19 for focusing light on ornear the retina of the eye and a cell barrier portion 21 circumscribingthe optical portion and being incapable of focusing light on the retina.Optical axis 22 passes through the center of optic 13 in a directiongenerally transverse to the plane of the optic.

In this embodiment, the optic 13 is circular in plan and biconvex;however, this is purely illustrative as other configurations and shapesmay be employed. The optic 13 may be constructed of any of the commonlyemployed materials commonly used for rigid optics, such aspolymethylmethacrylate (PMMA), or commonly used for resilientlydeformable optics, such as silicone polymeric materials, acrylicpolymeric materials, hydrogel-forming polymeric materials, mixturesthereof and the like.

The fixation members 15 and 17 in this embodiment are generally C-shapedand are integral with the optic 13. However, this is purely illustrativeas the fixation members 15 and 17 may be of other configurations and/ormay be separate members affixed to the optic in any of a variety ofconventional ways.

The optic 13 has an anterior face 23, a posterior face 25 and aperipheral edge 27. In this embodiment, the faces 23 and 25 are convexand the peripheral edge 27 is cylindrical, but as indicated above, theseshapes are shown only by way of example.

The optic 13 is designed to be placed in the capsular bag. The diameterof the optic 13 may be conventional, and as such, may be about 6 mm orless. The optical portion 19 performs the normal function of the opticof an IOL, i.e. to appropriately focus light at or near the retina. Theoptical portion 19 may be monofocal or multifocal.

In this embodiment, the cell barrier portion 21 is integral with theoptical portion 19. The cell barrier portion 21 is incapable of focusinglight on the retina of the eye and includes an irregularly configuredstructure or surface feature effective to inhibit, and preferablysubstantially prevent, cell growth radially inwardly across the cellbarrier portion. In the embodiment of FIGS. 1-6, the cell barrierportion 21 includes a concentric array of annular grooves 29 each ofwhich is at least partially defined by irregular surfaces. Similararrays of the grooves 29 are in both the anterior face 23 and theposterior face 25. Although various different arrangements can beemployed, in this embodiment the grooves 29 are concentric andsubstantially equally spaced apart. Each of the grooves 29 hassufficient irregularity in its structure so as to at least inhibitmigration of cells across the groove. For this purpose, each of thegrooves 29 has a maximum depth of no more than about 0.02 mm and amaximum width at the face 23 (or face 25 as the case may be) of no morethan about 0.005 mm or about 0.01 mm or about 0.02 mm. In addition, thegrooves 29 are substantially completely defined by irregular surfaces.In particular, each of the grooves 29 is represented by other thanstraight lines having a length more than about 0.001 mm, with the grooveviewed in axial cross-section along a plane which includes the opticalaxis 22. This irregularity of grooves 29 is illustrated in detail inFIG. 5. FIG. 6 is a photograph of a number of the grooves 29 whichdemonstrate their substantial irregularity.

Without wishing to limit the invention to any particular theory ofoperation, it is believed that the irregularly configured structure ofcell barrier portion 21, for example, grooves 29, acts to disrupt orotherwise interfere with the process of eye cell, for example, lensepithelial cell, migration or growth so that the cumulative effect ofthis irregular structure is to significantly reduce, or even eliminate,the migration or growth of cells in front of or in back of the opticalportion 19 after IOL 11 is implanted in the eye. FIG. 4 illustrates thateye cells 30 from the capsular bag 32 do migrate or grow to some extentonto and cover a portion of the cell barrier portion 21. This limitedcell migration is advantageous in at least assisting or facilitating theeffective fixation of IOL 11 in the eye. Thus, the present inventionpreferably provides for such advantageous limited eye lens epithelialcell migration or growth while preventing excessive cell migration orgrowth in front of or in back of the optical portion 19, as shown inFIG. 4.

Another way of viewing the degree of irregularity of the irregularlyconfigured structure, for example, grooves 29, on cell barrier portion21 is opacity. The grooves 29 are sufficiently irregular so that thecell barrier portion 21 is substantially completely opaque to thetransmission of light. When viewed by the naked eye, cell barrierportion 21 is a white or frosty band on the otherwise optically clearoptic 13.

The irregularity of grooves 29 is in contrast to the regular or orderedgrooves of the prior art, for example, the linear ordered groovesdisclosed in Kelman U.S. Pat. No. 4,808,181. The Kelman grooves aredefined as being ordered whereas the present grooves, such as grooves29, are defined by irregular, even randomly or unordered, surfaces, asdescribed elsewhere herein. Under 1000 times magnification, the Kelmangrooves are still defined (in axial cross-section) by straight lines.FIGS. 5 and 6 show that grooves 29, in accordance with the presentinvention, are not defined (in axial cross-section) by straight lines.Also, although the region of the Kelman IOL which includes the linearordered grooves may be somewhat distorted (not totally optically clear),this region still remains substantially transparent to the passage oflight. In contrast, the present grooves 29 and cell barrier portion 21are substantially opaque to the transmission of light. As noted above,the irregularity of the present cell barrier portion is an importantaspect of the present invention in inhibiting the migration of eye cellsonto the optical portion of the optic and clearly distinguishes thepresent IOLs from prior art IOLs, such as the IOLs of Kelman U.S. Pat.No. 4,808,181 and the like IOL which included regular or ordered surfacegrooves and the like features.

Preferably, the radial dimension of the cell barrier portion 21 is nogreater than about 2 mm, and more preferably no greater than 0.25 mm. Inthe embodiment shown in FIGS. 1 to 6, the spacing between the grooves 29along the face 23 may be about 0.005 mm to about 0.02 mm and the radialspacing between the outermost groove 29 and the peripheral edge 27 maybe about 0.02 mm to about 0.1 mm.

In the embodiment shown in FIGS. 1 to 6, the number of grooves 29 isabout 50 to about 100. In order to obtain an advantageous degree of cellmigration inhibition, it is preferred that the number of groovesincluded in cell barrier portion 21 be at least about 20, although fewergrooves can provide some useful benefits.

The grooves 29 are located wherever it is desired to inhibit cellmigration. In the present embodiment, the grooves 29 are placed on boththe anterior face 23 and the posterior face 25 so that the cell barrierportion 21 is on both faces of the optic 13. However, the cell barrierportion can be eliminated from a particular face if it is determinedthat cell migration in front of that face is not likely to occur.

The IOL 11 can be implanted in the capsular bag of the eye in accordancewith conventional techniques. When so implanted, the cell barrierportion 21 defines a radially relatively narrow annular barrier forinhibiting cell growth radially inwardly in front of or in back of theoptical portion 19 where the cells could cause secondary opacification.

The present invention is applicable to IOLs including a hard or rigidoptic, such as the optics made from PMMA, and those which include afoldable or deformable optic, such as optics comprising siliconepolymeric materials, other acrylic polymeric materials, hydrogel-formingpolymeric materials, such as polyhydroxyethylmethacrylate (poly HEMA),and the like. Such foldable/deformable optics are particularlyadvantageous since they can be inserted into the eye through a smallincision. The fixation members 15 and 17, are flexible and strandlike orfilaments so that they can be easily inserted into the eye. The fixationmembers 15 and 17 can be formed integrally with the optic 13 or can beseparately coupled to the optic.

FIGS. 7 and 8 show an IOL 11a which is identical to the IOL 11 in allrespects not shown or described herein. Portions of the IOL 11acorresponding to portions of the IOL 11 are designated by correspondingreference numerals followed by the letter a.

The only difference between the IOL's 11 and 11a is that in the IOL 11athe grooves 29 are replaced with an irregularly roughened or texturedsurface 31. The cell barrier portion 21a, in particular the roughened ortextured surface 31, is sufficiently irregular as to be at leastpartially, and preferably substantially completely, opaque to thetransmission of light. This not only provides cell migration inhibition,but also avoids glare from the interaction of light with the cellbarrier portion 21a. The textured surface 31 may be textured orroughened in any of a variety of ways including machining as with alathe, chemical etching, abrading or the like. If the optic 13a ismolded, as for example when it is constructed of silicone polymericmaterial or other soft foldable material, the texturing or roughening ofthe textured surface 31 may be imparted by the mold.

The degree of irregularity of the roughening of the surface 31 should besufficient to enable the textured surface to perform the inhibition ofcell migration function.

FIGS. 9 and 10 show an IOL 11b which is identical to the IOL 11 in allrespects not shown or described herein. Portions of the IOL 11bcorresponding to portions of the IOL 11 are designated by correspondingreference numerals follows by the letter b.

There are two primary differences between the IOL's 11b and 11. First,in the IOL 11b, the fixation members 15b and 17b are separate strands orfilaments which are attached to the optic 13b in a suitable conventionalmanner. Secondly, the cell barrier portion 21b is in the form of aseparate member coupled to the optical portion 19b.

In this embodiment, the cell barrier 21b includes spaced members 33joined by a web 35. The members 33 engage the faces 23b and 25b,respectively, and the web 35 confronts and engages the peripheral edge27b. The cell barrier portion 21b is annular and extends completelyaround the optical portion 19b and is mounted on the optical portion ina manner similar to a tire. The cell barrier portion 21b may have aradial width of up to about 2 mm or about 1 mm, for example, about 0.25mm.

While this invention has been described with respect to various specificexamples and embodiments, it is to be understood that the invention isnot limited thereto and that it can be variously practiced within thescope of the following claims.

What is claimed is:
 1. A method of inserting an intraocular lens whichcomprises:implanting an intraocular lens including an optical portion inan eye having a capsular bag so that said optical portion is placed insaid capsular bag, said optical portion being adapted for directinglight toward the retina of the eye; said intraocular lens including atleast one fixation member coupled to said optical portion for use infixing said intraocular lens in said eye, and a cell barrier portioneffective in inhibiting cell growth from said eye in front of or in backof said optical portion, said cell barrier portion circumscribing saidoptical portion, including an irregularly configured structure and beingincapable of focusing light on the retina.
 2. The method of claim 1wherein said irregularly configured structure is sufficiently irregularso as to be at least about 50% opaque.
 3. The method of claim 1 whereinsaid irregularly configured structure includes an irregularly roughenedregion.
 4. The method of claim 1 wherein said at least one fixationmember in elongated and said irregularly configured structure includesat least one annular groove at least partially defined by irregularsurfaces.
 5. The method of claim 1 wherein said irregularly configuredstructure includes a plurality of annular grooves each of which is atleast partially defined by irregular surfaces.
 6. The method of claim 1wherein said irregularly configured structure includes at least about 20annular grooves each of which is at least partially defined by irregularsurfaces.
 7. The method of claim 1 wherein said cell barrier portion hasanterior and posterior faces and includes said irregularly configuredstructure on one of said faces.
 8. The method of claim 7 wherein saidirregularly configured structure includes at least one annular groove atleast partially defined by irregular surfaces on one of said faces. 9.The method of claim 7 wherein said irregularly configured structureincludes an irregularly roughened region on at least one of said faces.10. The method of claim 1 wherein said cell barrier portion has a radialdimension of no more than about 2 mm.
 11. A method of inserting anintraocular lens which comprises:implanting an intraocular lensincluding an optic in an eye having a capsular bag so that said optic isplaced in said capsular bag, said optic including an optical portion fordirecting light toward the retina of the eye; said intraocular lensincluding a cell barrier portion effective in inhibiting cell growthfrom said eye in front of or in back of said optical portion, said cellbarrier portion circumscribing said optical portion, including anirregularly configured structure and being incapable of focusing lighton the retina, said intraocular lens further including a member otherthan said cell barrier portion effective in fixing said optic in saideye.
 12. The method of claim 11 wherein said irregularly configuredstructure is sufficiently irregular so as to be at least about 50%opaque.
 13. The method of claim 11 wherein said irregularly configuredstructure includes an irregularly roughened region.
 14. The method ofclaim 11 wherein said irregularly configured structure includes at leastone annular groove at least partially defined by irregular surfaces. 15.The method of claim 11 wherein said irregularly configured structureincludes a plurality of annular grooves each of which is at leastpartially defined by irregular surfaces.
 16. The method of claim 11wherein said optic has anterior and posterior faces and said cellbarrier portion includes an irregularly roughened surface region on oneof said faces.
 17. The method of claim 11 wherein said optic hasanterior and posterior faces and said irregularly configured structureincludes at least one annular groove at least partially defined byirregular surfaces on one of said faces.
 18. The method of claim 11wherein said optic is resiliently deformable.
 19. The method of claim 11wherein said optic comprises a material selected from the groupconsisting of polymethylmethacrylate, silicone polymeric materials,acrylic polymeric materials, hydrogel-forming polymeric materials andmixtures thereof.
 20. The method of claim 11 wherein said opticalportion has an anterior face, a posterior face and a peripheral edge andsaid cell barrier portion includes spaced legs joined by a web, saidlegs engage said faces, respectively, of said optical portion and saidweb confronts the peripheral edge.